Swedish Medical Products Agency (MPA, Läkemedelsverket) closes investigation into Natural Cycles
STOCKHOLM, Sweden, September 13, 2018 - The Swedish Medical Products Agency (MPA, Läkemedelsverket) has today informed Natural Cycles that its investigation has been closed. The MPA reviewed the rate of reported unintended pregnancies among Natural Cycles users between January and June 2018 and found the number to be in-line with the published typical use effectiveness rate of 93%, which is based on a study of over 22,000 women (1).
“We are pleased that the MPA has concluded its investigation, following a review of our real-world effectiveness data,” says Raoul Scherwitzl, Natural Cycles CEO. “There has been a lot of discussion about this investigation, and we hope that it will provide some reassurance to women to see eminent bodies like the Swedish MPA and the US FDA in alignment based on the strength of our clinical evidence. We never doubted the effectiveness of our product since the number of reported pregnancies is monitored closely on a monthly basis – this is an ongoing responsibility that we commit to as part of operating in a regulated environment.”
The MPA requested that Natural Cycles clarify the risk of unintended pregnancy in the instructions for use and in the app, and make some updates to the procedure for tracing and handling of software versioning. However, Natural Cycles was able to demonstrate that these changes had already been implemented earlier this year. The MPA was satisfied with these updates and the investigation was closed with no further action required by Natural Cycles.
Last month, Natural Cycles became the first app to be cleared by the Food and Drug Administration (FDA) as a method of contraception in the US.
Natural Cycles may be suitable for women who are looking for a natural method of contraception and have a lifestyle that enables them to take their temperature first thing most mornings. To use Natural Cycles, women must be willing to use protection or abstain from sex on red (fertile) days. Only barrier methods such as condoms protect against sexually transmitted infections (STIs). For those women who are ready to start a family, Natural Cycles can also be used to help plan a pregnancy by identifying their most fertile days.
NOTES TO EDITORS
About Natural Cycles
Natural Cycles was founded in June 2013 by former CERN physicist, Dr. Elina Berglund and her husband Dr. Raoul Scherwitzl, who also has a background in physics. Natural Cycles is an effective, natural method of contraception that is delivered in the form of an app. It uses a smart algorithm that is sensitive to subtle patterns in a woman’s cycle to accurately map daily fertility, based on basal body temperature. Natural Cycles is the first app to be cleared by the FDA and CE marked in Europe for use as a contraceptive, and its typical use effectiveness rate of 93% is supported by clinical data. The app can also be used to help plan a pregnancy when the time is right. Natural Cycles’ mission is to pioneer women’s health with research and passion, by empowering every woman the knowledge she needs to be in charge of her health. Natural Cycles is headquartered in Sweden and has operations in Germany, Switzerland, the United Kingdom and is establishing a presence in the United States.
For more information, please contact email@example.com
Read more: www.naturalcycles.com
(1) Berglund Scherwitzl E, et al. Contraception. 2017;96(6):420–425
The number of unintended pregnancies was found to have remained stable and in-line with the typical use effectiveness rate established in clinical studies